CSV Consultant

We are Capgemini Engineering. A brand part of the Capgemini Group.

We have the mission to empower every person and every organization on the planet to achieve more. Our culture is centered on embracing a growth mindset, diversity, inclusion, a purpose of inspiring excellence, and encouraging teams and leaders to bring their best each day. In doing so, we create life-changing innovations that impact billions of lives around the world.

You can help us to achieve our mission

Now, we have more than 270,000 team members in nearly 50 countries, in sectors such as aeronautics, automotive, communications, energy, life sciences, software & internet, space & defense and consumer products.

We're seeking a partner who shares knowledge, responsibility and commitment in the execution of activities related with the day-to-day business activity, namely in the CSV/QA area.

This position is open for Lisbon, Porto & Fundão.

Your role:

Perform as a CSV engineer supporting computerized system validation and IT qualification of applications and software;

Anticipate and advise about GxP-regulated and regulatory compliance computerized validation processes needs based on each system specifications;

Perform QA activities supporting Medical Devices software development projects;

Perform end-to end validation to verify software (validation planning, test protocols and reports, risk assessments);

Work within a team with specific roles following regulations and guidelines interacting with other teams and stakeholders;

Share knowledge about computerized system validation and medical devices.

Your profile:

Academic degree in biomedical engineering, pharmaceutical sciences, IT or computer science or related fields;

Previous experience in computerized system validation – CSV, ideally 2 to 5 years;

Strong knowledge of GxP regulations and guidelines;

Solid verbal and written communication skills in English (at least B2).